A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE (NCT07245407) — China Trial Details

Condition(s) studied

Non-cystic Fibrosis Bronchiectasis

Investigational drug(s) / intervention(s)

Participant Follow-up

Participant Follow-up: This is a longitudinal multi-center, observational, translational study which includes patients with a physician diagnosis of NCFBE by chest HRCT and healthy controls (at baseline only). This study will consist of a baseline visit, a 6-month (site visit or telephone visit) and a 12-month visit as well as planned unscheduled visits for exacerbation events and one optional visit for bronchoscopy.Healthy participants will be only enrolled in the baseline visit and bronchoscopy visit.

Study summary

Non-cystic ﬁbrosis bronchiectasis (NCFBE) is a chronic respiratory disease characterized by a clinical syndrome of chronic productive cough and recurrent respiratory infections in the presence of abnormal and permanent dilation of the bronchi. Recent epidemiological studies have clearly shown that the prevalence and incidence of NCFBE are quickly rising both in high- and low-income countries. With the increase of prevalence, bronchiectasis brings huge medical and economic burden to the society.

In this study, the investigator will perform biomarker assessments and multi-omics analysis on NCFBE patients and healthy participants in China to validate the link of disease pathways to pathophysiological features and uncover the molecular endotypes behind clinical phenotypesof Chinese patients with NCFBE.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: Healthy control cohort: · Age ≥30 years Bronchiectasis cohort: * Capable of giving signed informed consent. * Participant must be ≥18 years of age, at the time of signing the ICF. * Able to perform acceptable lung function testing according to ATS/ERS 2019 acceptability criteria. * Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center, and use electronic devices (e.g. FENO and spirometry). * Documented physician-diagnosed bronchiectasis: with a clinical history consistent with bronchiectasis (chronic cough and daily sputum production etc.) and having performed chest HRCT indicating bronchiectasis. * Remaining clinically stable upon recruitment. Patients with exacerbations are allowed to be enrolled into the study at least 4 weeks after the end of exacerbations. If a patient experiencing exacerbation and directly enters the exacerbation visit, the patient is required to come to the study site for baseline visit (after confirming that all inclusion/exclusion criteria are met) within 4 weeks /+ 3 days after the end of exacerbation Exclusion Criteria: Healthy control cohort: * Any respiratory diagnosis (asthma, COPD, bronchiectasis, pulmonary fibrosis or any other chronic respiratory condition requiring regular treatment). * Inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, any other connective tissue disease. * Active malignancy excluding non-melanoma skin cancer. * Antibiotic treatment for an acute respiratory tract infection in the previous 4 weeks or current sinusitis. * Any contraindication to study procedures including bronchoscopy. * Current smoking or smoking in the preceding 3 months. * Treatment with anti-coagulants. Bronchiectasis cohort: * Traction bronchiectasis associated with interstitial lung disease or other pulmonary disorders (e.g., pulmonary fibrosis and cystic fibrosis). * Primary diagnosis of another pulmonary condition, including COPD, asthma. Patients with a secondary diagnosis of these pulmonary diseases will be allowed to participate as long as bronchiectasis is considered by the investigator to be the primary diagnosis. * Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could: * Affect the safety of the participant throughout the study * Influence the findings of the study or the interpretation * Impede the participant's ability to complete the entire duration of study * The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation. * Active malignancy excluding non-melanoma skin cancer. * Participants is female who is pregnant or lactating or up to 6 weeks post-partum or 6 weeks cessation of breastfeeding. * The participant has an altered mental status at the time of informed consent. * History or current evidence of an upper or lower respiratory infection or symptoms(including common cold) within 2 weeks of baseline assessments * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study center). * Terminal disease and/or organ failure or participants otherwise considered not appropriate for the study participation.

Primary outcome measure(s)

FEV1/FVC% — 12 month
Evaluation of lung function
FEF25-75 L/s — 12 month
Evaluation of small airway function
FENO ppb — 12 month
Evaluation of airway inflammation: FENO.
HRCT — 12 month
Evaluation of lung structure profile and change through radiological parameters.
cell percentage (%) — 12 month
Measurement of immune cell (including but not limited to neutrophils and eosinophils) percentages in blood
Gene expression read counts by RNAseq — 12 month
Functional and transcriptional characterization of airway immune cells, bronchial epithelial cells andsmooth muscle cells (optional).
Molecular deliverables — 12 month
MUC5AC/5B in sputum
on-set age(years-old) — 12 month
Risk factor assessment: on-set age(years-old)
Sex(M/F) — 12 month
Risk factor assessment: Sex(M/F)
body mass index(kg/m^2) — 12 month
Risk factor assessment: body mass index(kg/m\^2)
comorbidities — 12 month
Risk factor assessment: comorbidities
medical history — 12 month
Risk factor assessment: medical history, especially TB history
smoking status(never/current/former) — 12 month
Risk factor assessment: smoking status(never/current/former)
smoking pack years(pack/year) — 12 month
Risk factor assessment: smoking pack years(pack/year)
Sputum microbiology (CFU) — 12 month
Bronchiectasis aetiology evaluation
Historical Exacerbation — 12 month
Risk factor assessment: exacerbation number in the previous year
BSI score — 12 month
Evaluation of ronchiectasis disease severity: BSI score(0-4 mild,5-8 moderate, ≥9 severe)
QoL-B-RSS — 12 month
Evaluation of quality of life: Patient reported outcome: QoL-B-RSS (0-100, higher score stands for lower symptom burden and higher quality of life)
BHQ — 12 month
Evaluation of quality of life: Patient reported outcome: BHQ(10-70,higher score stands for higher symptom burden and pooer quality of life )
BEST — 12 month
eDiary: BEST(MCID 4 points may standfor an exacerbation.)
Treatment pattern — 12 month
Evaluation of treatment pattern: inhaled antibiotic, macrolide, and mucoactive drugs,etc.
Exacerbation assessment — 12 month
Exacerbation assessment: number of exacerbations per patient per year
Cell counts (10^9/L) — 12 month
Measurement of immune cell (including but not limited to neutrophils and eosinophils) counts in blood
Exacerbation assessment about hospitalization — 12 month
Exacerbation assessment: number of exacerbations lead to hospitalization per patient per year

Trial sites (38)

Facility	City	Region
Beijing Chaoyang Hospital Affiliated to Capital Medical University	Beijing	Beijing Municipality
Beijing Hospital	Beijing	Beijing Municipality
Peking University People's Hospital	Beijing	Beijing Municipality
The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality
The Second Affiliated Hospital of Fujian Medical University	Quanzhou	Fujian
Gansu Provincial Hospital	Lanzhou	Gansu
Shenzhen People's Hospital	Shenzhen	Guangdong
Affiliated Hospital of Guangdong Medical University"	Zhanjiang	Guangdong
The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
Guizhou Provincial People's Hospital	Guiyang	Guizhou
Henan Provincial People's Hospital	Zhengzhou	Henan
Zhengzhou People's Hospital	Zhengzhou	Henan
Shiyan Taihe Hospital	Shiya	Hubei
Xiangya Hospital of Central South University	Changsha	Hunan
The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
The Second Hospital of Jilin University	Changchun	Jilin
Weifang People's Hospital	Weifang	Shandong
Huadong Hospital Affiliated to Fudan University	Shanghai	Shanghai Municipality
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality
Shanghai Fifth People's Hospital	Shanghai	Shanghai Municipality
Shanghai General Hospital	Shanghai	Shanghai Municipality
Shanghai Pulmonary Hospital	Shanghai	Shanghai Municipality
Shanghai Tongji Hospital	Shanghai	Shanghai Municipality
Zhongshan Hospital Affiliated to FuDan University"	Shanghai	Shanghai Municipality
Chengdu Fifth People's Hospital	Chengdu	Sichuan
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital	Chengdu	Sichuan
West China Hospital of Sichuan University	Chengdu	Sichuan
Anning First People's Hospital	Anning	Yunnan
The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
Jiaxing Second Hospital	Jiaxing	Zhejiang
Ningbo Fenghua District People's Hospital	Ningbo	Zhejiang
The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
Huzhou Central Hospital	Huzhou	Zhejing
Jiaxing First Hospital	Jiaxing	Zhejing
The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Zhengzhou

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